Stapler Post-market Observational Study
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|ClinicalTrials.gov Identifier: NCT02922205|
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : February 8, 2019
|Condition or disease||Intervention/treatment|
|Observational||Device: Endoscopic Linear Cutter Stapler and reloads|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||24 Months|
|Official Title:||Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.|
|Actual Study Start Date :||April 6, 2017|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||June 2021|
Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery.
Device: Endoscopic Linear Cutter Stapler and reloads
Endoscopic Linear Cutter Stapler and reloads
- Number of patients with adverse events related to the index-procedure. [ Time Frame: 1 month follow-up ]Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
- Number of patients with adverse events related to the index-procedure. [ Time Frame: 6 months follow-up ]Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
- Number of adverse device effects. [ Time Frame: 1, 6, 12 and 24 month follow-up ]Determination of staple line disruption.
- Number of patients with bariatric surgery related re-interventions. [ Time Frame: 1, 6, 12 and 24 month follow-up ]
- Percentage of excess weight loss. [ Time Frame: 1, 6, 12 and month follow-up ]pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg).
- Questionnaire on food tolerance. [ Time Frame: 1, 6, 12 and 24 month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922205
|Contact: Dorien Haesenfirstname.lastname@example.org|
|Genk, Limburg, Belgium, 3600|
|Contact: Hans Verhelst, Dr. +32 89 32 60 20 email@example.com|
|Principal Investigator:||Hans Verhelst, Dr.||ZOL, Genk|